20/20 BioResponse will shortly begin offering a new and cutting edge COVID-19 antibody testing service in our CLIA licensed lab, located in Rockville MD. Since 2012, we have been running high complexity testing in our CLIA certified laboratory to medical professionals, public health agencies, and first-responders throughout the US since 2012.
About the test
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus.
What is an antibody test?
An antibody test detects antibodies that an individual produces after exposure to a pathogen such as the novel coronavirus. A serology test is a diagnostic test involving blood serum—the part of a person’s blood that contains proteins other than those involved in blood clotting. Roche’s new test is both an antibody test and a serology test in that it uses blood serum to determine the presence of antibodies associated with exposure to the SARS-CoV-2 virus. From patients, blood samples drawn by health-care professionals are required, similar in size to samples drawn for common lab tests.
Based on the measurement of a total of 5272 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population.
On May 3, 2020, Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA)1 for its new Elecsys® Anti-SARS-CoV-2 antibody test.
How is the test run?
The test is run on a Roche Cobas e analyzer, which are widely used around the world. The automated Cobas e system can process SARS-CoV-2 tests in approximately 18 minutes. This instrument platform is different than the platforms used to perform molecular tests for SARS-CoV-2, also known as nucleic acid RT-PCR tests.
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